Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 25 hours ago

Senior Manager, Regulatory Affairs

LabConnect26 open roles

Where
Remote - EU (Köln), Köln, Nordrhein-Westfalen, Germany
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior Manager, Regulatory AffairsLabConnect · Remote - EU (Köln), Köln, Nordrhein-Westfalen, Germany

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on LabConnect's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market. LabConnect postings stay open a median of 20 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 25 hours ago

LabConnect median: 20 days open

The posting

Job Summary The Senior Manager, Regulatory Affairs plays a critical role in safeguarding the organization against quality and regulatory risks. By ensuring that operations are both efficient and compliant, they will support the department maintain compliance with global regulatory and quality processes support of clinical trial and other projects operational activities related to laboratory testing. Essential Duties and Responsibilities

Support the Senior Director in developing and executing regional regulatory strategies for LabConnect initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Collaborate with cross-functional teams to integrate LabConnect considerations into process development, for clinical and real-world evidence studies. Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director. Contribute to managing regulatory risks and opportunities related to LabConnect projects and assist in developing mitigation strategies as needed. Provide regulatory guidance and support for clinical and post-marketing activities related to LabConnect projects. Assist in preparing regulatory updates, regulatory intelligence for governance committees. Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the operations team in a timely and professional manner

Education and Experience

Bachelor's degree in scientific disciplines such as life sciences, pharmacy, bioscience; advanced degree preferred. 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on clinical research preferred. 3+ years of people leadership experience required. Strong knowledge of regional regulatory requirements and guidelines, including country specific regulations and ICH guidelines.

Skills and Ability

Leadership, presence, judgement, communication, and client-engagement skills to effectively operate at the executive level. Thrives in building highly effective teams; possesses strong people management skills. Demonstrated ability to work effectively in a cross-functional team environment. Excellent communication and interpersonal skills. Ability to assist in developing and executing regulatory strategies tailored to specific regions. Strong organizational skills with attention to detail. Ability to collaborate effectively with cross-functional teams. Awareness of regulatory developments and trends within specific regions. Strong analytical and problem-solving skills. Ability to work independently and prioritize tasks effectively.

Supervisory Responsibilities: Manager Physical Demands: While performing the duties of this job, the occupant is regularly required to:

Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment.

Travel Requirements: Minimal One Global Team At LabConnect, we are proud to be one global team: united by our shared mission to advance clinical trials through innovation, agility, and collaboration. We believe that our people are our greatest asset, and we are committed to fostering a workplace that reflects our core values: People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always. LabConnect is an Equal Opportunity Employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), creed, national origin, age, disability, genetic information, veteran status, or any other legally protected status. We are committed to cultivating a workplace that is safe, equitable, and respectful for all. Together, as one global team, we strive to ensure that every individual has the opportunity to thrive and contribute to our shared success.

This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against LabConnect's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on LabConnect's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    LabConnect's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.